27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the treatment of patients with ROS1 positive metastatic non-small-cell lung cancer who have been previously treated with two or more ROS1 tyrosine kinase inhibitors.

NVL-520 is a novel brain penetrant ROS1 selective tyrosine kinase inhibitor created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system adverse events associated with inhibition of the structurally related tropomyosin receptor kinase family that may limit the use of currently available ROS1 tyrosine kinase inhibitors.

Read Nuvalent press release